NF ISO 20916:2019
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
In vitro diagnostic medical devices — Clinical performance studies using specimens from human subjects — Good study practice
Hardcopy
04-04-2024
English - French
01-09-2019
This document defines good study practice for the planning, design, conduct, recording and reporting of clinical performance studies carried out to assess the clinical performance and safety of in vitro diagnostic (IVD) medical devices for regulatory purposes.
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